Robotic Versus Open Ventral Hernia Repair

Not Applicable

Recruiting

• Conditions: Ventral Hernia
• Interventions: Procedure: Ventral Hernia Repair

• Registration Number: NCT05472987
• Lead Sponsor: Lucas Beffa

Brief Summary

This is a randomized trial comparing open retromuscular ventral hernia repair to robotic retromuscular ventral hernia repair.

Detailed Description

This is a randomized trial comparing open retromuscular ventral hernia repair to robotic retromuscular ventral hernia repair. This is a superiority trial with a primary outcome of length of stay in the hospital, theorizing that robotic retromuscular ventral hernia repairs are superior to open ventral hernia repairs by reducing length of stay by 24 hours. Patients will be blinded to the intervention, groups will be in parallel, and the primary outcome (when the patient is discharged) will be determined by a blinded assessor.

Study Timeline

• Study First Submitted: 2022-07-20
• Study First Submitted QC: 2022-07-21
• Study Start: 2022-07-25
• Study First Posted: 2022-07-25
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-14
• Primary Completion: 2025-08-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 18 years and older
• 7 cm to 15 cm wide hernia midline defects
• BMI less than or equal to 45
• Patient deemed both an open and robotic candidate by operating surgeon

Exclusion Criteria

• 17 years old or younger
• prisoners
• pregnant patients
• Emergent patients
• BMI greater than 45
• Hernia defects less than 7 cm or greater than 15 cm in width

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robotic Ventral Hernia Repair	Ventral Hernia Repair	These patients will undergo robotic retromuscular ventral hernia repairs.
Open Ventral Hernia Repair	Ventral Hernia Repair	These patients will undergo open retromuscular ventral hernia repairs

Primary Outcome Measures

Name	Time	Method
Length of Stay	30 days	Time in the hospital after the surgery

Secondary Outcome Measures

Name	Time	Method
Post-operative wound complications	30 day and one year	any abnormal wound healing
Readmission rate	30 days	Readmission to the hospital within 30 days of the surgery
Opioid consumption	30 days and one year	Opioid prescribed and consumed
Acute pain scores	5 days after surgery	Numeric Rating Scale-11 pain scores daily, 0-10 with 0 being no pain and 10 being the worst pain for first five days after surgery
Hernia recurrence	30 days and one year	Hernia recurrence
Quality of life scores using European Hernia Society (EuraHS) scale	30 day and one year	EuraHS is a hernia specific quality of life scale with three domains: pain, restrictions of activity, and cosmesis. 0-30 with higher scores indicating a worse quality of life.
Other post operative complications	30 days	Heart attacks, acute kidney injury, admissions to ICU, respiratory failure
Direct cost	30 days	Cost to the hospital
Hernia Related Specific Quality of Life Score	30 days and one year	Score of 0-100 with lower scores indicating worse quality of life

Trial Locations

Locations (4)

University of Florida Health; 🇺🇸 Gainesville, Florida, United States

Prisma Health Greenville Memorial Hospital; 🇺🇸 Greenville, South Carolina, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

University of Tennessee Medical Center, Knoxville; 🇺🇸 Knoxville, Tennessee, United States